Flunisolide Pregnancy Warnings

Use is not recommended unless the benefit outweighs the risk to the fetus

US FDA pregnancy category: C

Comments: -Asthma should be closely monitored and medication adjusted as necessary to maintain optimal asthma control in pregnant women. -Infants exposed to corticosteroids in utero should be observed for signs and symptoms of hypoadrenalism.

Animal studies in rats and rabbits have shown teratogenicity and fetotoxicity in doses approximately 1 and 3 times the maximum recommended daily inhalation dose (on a mg/m2 basis), respectively. Experience with pharmacologic doses of oral corticosteroids suggests rodents may be more prone to teratogenic effects than humans. There are no adequate and well-controlled studies in pregnant women.

In a review of 229,101 deliveries to Michigan Medicaid patients, 141 first-trimester exposures to flunisolide and 322 exposures anytime during pregnancy were recorded. A total of 5 birth defects were reported with first-trimester exposures (5 expected). (written communication, Franz Rosa, MD, Food and Drug Administration, 1994) These data do not support an association with adverse fetal outcome.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.